Preventing the development and progression of diabetic kidney disease: Where do we stand?

Zagkotsis, Georgios; Markou, M.; Paschou, Eleni; Papanikolaou, Panagiota; Sabanis, Nikos

doi:10.1016/j.dsx.2018.03.012

Cited by 9 publications

(6 citation statements)

References 54 publications

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“…Methods to control DKD are urgently needed due to the increasingly high incidence of diabetes worldwide. Treatment of DKD mainly focuses on glycemic control, blood pressure reduction, and renin-angiotensin-aldosterone system (RAAS) blockade [17,18]. TCM plays considerable roles in symptom and quality of life improvement for DKD patients in China.…”

Section: Discussionmentioning

confidence: 99%

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Wei²,

Fan

et al. 2020

Preprint

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Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a KLX treatment group (n=126) or a placebo control group (n=126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in the estimated glomerular filtration rate (eGFR; ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR >30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the traditional Chinese medicine (TCM) syndrome scale scores.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

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Section: Discussionmentioning

confidence: 99%

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Wei²,

Fan

et al. 2020

Preprint

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show abstract

“…Methods to control DKD are urgently needed due to the increasingly high incidence of diabetes worldwide. Treatment of DKD mainly focuses on glycemic control, blood pressure reduction, and renin-angiotensin-aldosterone system (RAAS) blockade [23,24]. TCM plays considerable roles in symptom and quality of life improvement for DKD patients in China.…”

Section: Discussionmentioning

confidence: 99%

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Wei²,

Wei

et al. 2020

Preprint

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Background: Diabetic kidney disease (DKD) is one of the most important microvascular complications of diabetes, and its prevalence has increased dramatically in the past few decades. DKD is responsible for considerable morbidity and mortality of patients with diabetes. Keluoxin capsule (KLX) is a Chinese patent medicine that has been used in the clinic to control DKD for years. Previous studies have shown that KLX appears to reduce proteinuria, but the study protocols as well as the primary outcome need to be improved. Thus, we aim to evaluate whether losartan potassium combined with KLX is more effective than losartan potassium in DKD treatment and to provide validated evidence for the application of KLX in the treatment of DKD.Methods: We will conduct a randomized double-blind placebo-controlled multicenter clinical trial. A total of 252 participants diagnosed with DKD recruited from 18 institutions will be randomly allocated to either a losartan potassium plus KLX (n=126) a losartan potassium plus placebo group (n=126). The participants will be administered KLX or placebo in addition to losartan potassium for 24 weeks. The primary outcome measure will be the decline in estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2/year) from baseline within 24 weeks, and the secondary outcomes will be the incidence of serum creatinine doubling, the incidence of end-stage renal disease (ESRD), the proportion of subjects with a progressive decline in eGFR >30%, the percent change in 24 h urinary total protein (UTP), the change in the urinary albumin/creatinine ratio (UACR), and the total effective rate of the traditional Chinese medicine (TCM) syndrome scale scores. Comparison of the differences in the variables between groups will be performed according to the data revealed by independent t tests, chi-squared tests, Fisher exact tests or Wilcoxon tests. All statistical tests will be two-sided, and significance will be considered for p-values <0.05.Discussion: This study will be the first randomized clinical trial to evaluate the efficacy and safety of KLX versus the placebo for the treatment of patients with DKD. The outcome of this trial will provide a basis for prescribing KLX to patients with DKD.Trial registration: The trial was registered at Chinese Clinical Trial Registry (www.chictr.org.cn) under approval number ChiCTR1900021113 (approval date: 2019/01/29).

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“…Apart from the updated understanding of the advances of the molecular signals involved in the development of DKD, physicians are focusing on two major concerns about DKD, optimizing the process of diagnosis and designing precise strategies for the management of DKD patients in the clinic. In general, the natural history of DKD could be divided into five stages: the initial increased GFR due to hyperfiltration, the ‘silent’ phase, the ‘incipient’ phase, the ‘overt’ phase, and eventual development of ESRD [111]. However, it is clear that not all T2DM patients exactly follow this classic pattern of the development of kidney complications.…”

Section: Dkd In the Clinic: The Arena To Deal With The Devilmentioning

confidence: 99%

Diabetic kidney diseases revisited: A new perspective for a new era

Fu¹,

Liu

Bastacky

et al. 2019

Molecular Metabolism

166

115

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BackgroundGlobally, diabetic kidney disease (DKD) is the leading cause of end-stage renal disease. As the most common microvascular complication of diabetes, DKD is a thorny, clinical problem in terms of its diagnosis and management. Intensive glucose control in DKD could slow down but not significantly halt disease progression. Revisiting the tremendous advances that have occurred in the field would enhance recognition of DKD pathogenesis as well as improve our understanding of translational science in DKD in this new era.Scope of reviewIn this review, we summarize advances in the understanding of the local microenvironmental changes in diabetic kidneys and discuss the involvement of genetic and epigenetic factors in the pathogenesis of DKD. We also review DKD prevalence changes and analyze the challenges in optimizing the diagnostic approaches and management strategies for DKD in the clinic. As we enter the era of ‘big data’, we also explore the possibility of linking systems biology with translational medicine in DKD in the current healthcare system.Major conclusionNewer understanding of the structural changes of diabetic kidneys and mechanisms of DKD pathogenesis, as well as emergent research technologies will shed light on new methods of dealing with the existing clinical challenges of DKD.

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Preventing the development and progression of diabetic kidney disease: Where do we stand?

Cited by 9 publications

References 54 publications

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease with Qi and Yin Deficiency and Blood Stasis Syndrome: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Effects of Keluoxin Capsule Combined with Losartan Potassium on Diabetic Kidney Disease: Study Protocol for a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Trial

Diabetic kidney diseases revisited: A new perspective for a new era

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